BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-CCP

    MDR report key: 17273355 · Received July 6, 2023

    Report

    Report Number
    1823260-2023-02196
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Date of Event
    March 3, 2023
    Report Date
    September 12, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHX
    UDI-DI
    04015630940370
    PMA / PMN Number
    K081338
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE WAS REQUESTED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    A SAMPLE OF THE PATIENT WAS PROVIDED FOR INVESTIGATION. THE HIGH ELECSYS ANTI-CCP RESULT OF THE CUSTOMER COULD BE REPRODUCED. NO INTERFERING FACTOR AGAINST THE STREPTAVIDIN COMPONENT OF THE ASSAY COULD BE DETERMINED IN THE SAMPLE. BASED ON THE INVESTIGATION RESULTS, THE ELECSYS ANTI-CCP RESULT IS CONSIDERED TO BE TRUE POSITIVE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR SAMPLES FROM ONE PATIENT TESTED WITH THE ELECSYS ANTI-CCP ASSAY ON A COBAS E 801 ANALYTICAL UNIT (SERIAL NUMBER (B)(6)) AND COMPARED TO THE SIEMENS METHOD. AN INTERFERENCE IS SUSPECTED BY THE CUSTOMER. ON (B)(6)2023, A SAMPLE FROM THE PATIENT WAS TESTED USING THE ELECSYS ANTI-CCP ASSAY, RESULTING IN A VALUE OF 309 U/ML. ON (B)(6) 2023, A SAMPLE FROM THE PATIENT WAS TESTED USING THE ELECSYS ANTI-CCP ASSAY, RESULTING IN A VALUE OF 249 U/ML. ON (B)(6) 2023, A SAMPLE FROM THE PATIENT WAS TESTED USING THE SIEMENS ANTI-CCP METHOD, RESULTING IN A VALUE OF <0.5 KU/L. THIS RESULT IS CONSISTENT WITH THE PATIENT¿S CLINICAL PICTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421982 ELECSYS ANTI-CCP ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) NHX ROCHE DIAGNOSTICS NA 69025301 04015630940370

    Patients

    Seq Age Sex Outcome Treatment
    1 Female VIMOVO (2 TIMES/DAY).